| CTRI Number |
CTRI/2026/02/104108 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Calf Muscle Mobilization device to improve pain relief and functional mobility |
|
Scientific Title of Study
|
Design and validation of calf muscle mobilization device to improve pain relief and functional mobility |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhara Kotadiya |
| Designation |
Post Graduate student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School Of Physiotherapy - RK University Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot
Rajkot GUJARAT 360020 India |
| Phone |
9328553577 |
| Fax |
|
| Email |
dkothaidya874@rku.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Priyanshu V Rathod |
| Designation |
Professor and Dean Faculty of Medicine |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School Of Physiotherapy - RK University Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot
Rajkot GUJARAT 360020 India |
| Phone |
9426803108 |
| Fax |
|
| Email |
priyanshu.rathod@rku.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Priyanshu V Rathod |
| Designation |
Professor and Dean Faculty of Medicine |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School Of Physiotherapy - RK University Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot
Rajkot GUJARAT 360020 India |
| Phone |
9426803108 |
| Fax |
|
| Email |
priyanshu.rathod@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University, Bhavnagar Highway, Kasturbadham, Rajkot - 360020, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy- RK University |
| Address |
Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dhara Kotadiya |
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot- 360020, Gujrat, India.
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhara Kotadiya |
RK Physiotherapy Rehabilitation and Research Center |
Physiotherapy Department, Room no.1, opposite Meghani rang
bhavan, Bhaktinagar circle, Rajkot-360002, Gujarat, India
Rajkot
GUJARAT Rajkot GUJARAT |
9328553577
dkothaidya874@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With and Without Calf pain, spasm, and tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of Calf Muscle Mobilization Device on Healthy Individuals With or Without Calf Pain. |
The innovative device has been developed based on pneumatic compression and relaxation, a hand massage like movement with two cuff-like structure to mobilise the calf muscles from distal to proximal, As inflation and deflation time of each cuff is 7 and 8 seconds device will apply for total 8 minutes and after immediately post assessment will taken. After 2 weeks same procedures will taken and assessed. |
| Comparator Agent |
Effect of manual massage and stretching techniques on patient. |
Therapist will give manual massage and stretching to the patient .manual massage will given for 8 minutes and stretching will apply for 15 seconds hold, 3 repetition. After 2 weeks same procedures will taken and assessed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Written informed consent to participate in the study voluntarily.
2) Person with or without calf pain
|
|
| ExclusionCriteria |
| Details |
1)Mentally retarded patients
2)Open wounds |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)ankle dorsiflexion and plantarflexion range of motion (degrees) following intervention using the Calf Muscle Mobilization Device.
|
Baseline (Pre-intervention) and Immediately Post-intervention,2 weeks after baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)VAS scale for pain assessment
2)single leg stance test performance (eyes open & eyes closed)
3)single leg heel raise test performance (number of repetitions in 30 seconds)
4)QUEST 2.0 For user sefty,satisfaction & comfort
5)Timed up & go test for balance improvement
|
Baseline (Pre-intervention) & Immediately Post-intervention,2 weeks after baseline |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Calf muscle dysfunction, including pain, tightness, spasm, and venous congestion, is a frequent clinical problem affecting individuals across sedentary and physically active populations, often resulting in discomfort and impaired functional mobility. Conventional management approaches such as manual therapy, stretching, and compression modalities, while widely used, are commonly limited by therapist dependence, inconsistent application, and lack of standardization. To address these limitations, a self-operated device for calf muscle mobilization was designed and developed to deliver controlled, graded distal-to-proximal compression and soft tissue mobilization, simulating the physiological action of the calf muscle pump. This study aimed to design and validate the device and to evaluate its clinical effects on pain, muscle flexibility, balance, and functional performance. The device was engineered to produce standardized, repeatable dual mode (mild and moderate comression) compression–relaxation cycles (7+8 seconds) with adjustable intensity and treatment duration, emphasizing safety, comfort, and reproducibility. The evaluation will be done before and after the 5-10 minutes of device for calf muscle mobilization, including pain intensity assessed by the Visual Analogue Scale (VAS), ankle dorsiflexion range of motion (ROM) as an indicator of calf muscle flexibility, functional mobility measured through the Timed Up and Go (TUG) test, static balance assessed by the Single Leg Stand Test, and calf muscle endurance evaluated using the Single Leg Heel Raise Test. User satisfaction and perceived usability were assessed using the QUEST 2.0 questionnaire. Device reliability was also examined. The device functions by applying rhythmic, graded compression in a distal-to-proximal sequence, aiming to facilitate soft tissue mobilization, reduce muscle discomfort and tightness, and support venous return. The selected outcome measures (VAS, ankle dorsiflexion ROM, TUG, Single Leg Stand Test, Single Leg Heel Raise Test, and QUEST 2.0) enabled objective assessment of pain, flexibility, balance, muscular endurance, functional mobility, and user satisfaction following device use. This framework supports systematic evaluation of the device’s therapeutic utility and clinical applicability. |